Massachusetts Jobs

Company Overview

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

Responsibilities will include supporting Facilities and Calibration day-to-day planning, scheduling, CMMS system reporting, managing audits/findings and Quality Management System (QMS) reporting. The ideal candidate has prior experience in coordinating outside services to ensure timely response of maintenance/calibration activities, including repairs, as well as, proven excellent interpersonal skills.

Responsibilities

• Assisting with the processing, tracking, reviewing, and trending of GxP maintenance and calibration work orders through the computerized maintenance management system (CMMS)

• Collaborate cross functionally to schedule all Maintenance and Calibration activities

• Assist Department personnel with document updates and document processing for drawings, CAPAs, CCRs, SOPs, and other related document types

• Handling of variety of documents for training, drawing, maintenance, metrology, ETOP, and purchasing

• Supporting audits/findings and Quality Management System (QMS) reporting, track the status of CAPAs, AUDs, and CCRs and notify facilities personnel upcoming and overdue items

• Oversee Facility owned contracts/vendor selection for department budgeting

• Coordinate 3rd party offsite calibration activities (documentation and equipment)

• Track parts and inventory needs for critical spares for as needed

• Interact with Accounts Payable and Supply Chain to resolve inventory discrepancies including quantity and invoicing issues as they arise

• Must be proficient using Quality Management Software for CAPA exception initiation.

• Candidate in this position must have the capability to work independently, communicate effectively and are accountable for performance of tasks in a timely manner

Minimum Qualifications

• High school diploma

• 3-5 years of experience in an internal manufacturing environment with a minimum of 2+ years of GMP and administrative experience

• Minimum technical writing skills at a level necessary for reviewing/editing common documents processed by Operations technical staff, to support GMP requirements and the quality expectations of external clients

• Must possess excellent knowledge of standard Microsoft Office programs

• Must have excellent interpersonal skills and be timely and effective with communication

• Must possess excellent organizational skills

• Experience interfacing with multiple external vendors

• Ability to effectively communicate and collaborate with internal and external stakeholders

• Ability to work effectively in a collaborative team environment.

• Self-driven, independently motivated, data driven and excellent problem-solving ability

• Proficient in use of CMMS, BMS, and QMS systems

Preferred Qualifications

• Experience with Blue Mountain and/or Delta systems a plus

• Experience with overseeing parts and purchase ordering (Oracle) preferred

Competencies

• Collaborative – Openness, One Team

• Undaunted – Fearless, Can-do attitude

• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.

• Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

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